Dornier Medilas H Solvo 35 Laser
K-Number: K180350 · 2018-03-07
ApplicantDornier Medtech America
Decision Date2018-03-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dornier Medilas H Solvo 35 Laser is a medical device manufactured by Dornier Medtech America. It received FDA 510(k) clearance on 2018-03-07 under approval number K180350. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dornier Medilas H Solvo 35 Laser?
Dornier Medilas H Solvo 35 Laser is a medical device that received FDA 510(k) clearance on 2018-03-07. It is manufactured by Dornier Medtech America. The 510(k) number is K180350.
When was Dornier Medilas H Solvo 35 Laser approved by the FDA?
Dornier Medilas H Solvo 35 Laser received FDA 510(k) clearance on 2018-03-07, under approval number K180350.
What company makes Dornier Medilas H Solvo 35 Laser?
Dornier Medilas H Solvo 35 Laser is manufactured by Dornier Medtech America.
What is the FDA product code for Dornier Medilas H Solvo 35 Laser?
The FDA product code for Dornier Medilas H Solvo 35 Laser is GEX. This falls under the Gastroenterology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.